SOURCES, VERSIONS & WHAT CHANGED

FDA Orange Book reference: initial ACD release

Our first prepared Orange Book reference: product attributes, related patent and exclusivity records, and the source definitions needed to interpret them.

Source capture and ACD release

This is an ACD source capture from October 16, 2026. The FDA ZIP member timestamps are October 9; these are file metadata, not a verified coverage cutoff. FDA publishes the downloadable files monthly, but the retained files do not name a precise edition. Patent-use and exclusivity definitions were captured separately on October 16. There is no previous ACD Orange Book release to compare.

Preparation and source accounting

All 73,724 original bulk rows are accounted for. The source exclusivity file contains 74 exact duplicate rows: each remains traceable, while the prepared table represents the identical record once with its occurrence count. Product keys are unique, all patent/exclusivity relationships resolve to a product, and every used code has its FDA definition.

5,873 approvals are stated only as before January 1, 1982. Their exact-date column stays blank with an explicit status and source wording. Identifier zeros, patent RE prefixes and *PED suffixes are preserved. Separate tables prevent accidental multiplication when combining patents and exclusivities.

Using the release

Work through the Python portfolio example, or inspect the fields, sample and complete download. The captured source edition costs $29 once; ACD processing improvements for it are included. Future source editions may be sold separately.

Source: FDA Orange Book files. This research reference supplies no NDC linkage, clinical substitution recommendation or legal determination from listed dates. Independent preparation; no FDA endorsement.